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Soft Tissue Infections clinical trials

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NCT ID: NCT02796742 Completed - Clinical trials for Skin and Soft Tissue Infections (SSTIs)

S. Aureus, Skin and Soft Tissue Infections

SSTIs
Start date: June 2015
Phase: N/A
Study type: Observational

Methicillin-resistant Staphylococcus aureus (MRSA) is reported as one of the main causative pathogen of community acquired SSTIs. In the USA, high prevalence of MRSA among Skin and soft tissue infections (SSTIs) is known to be due to the spread of the USA300 clone [Moran et al. 2006]. Among S. aureus SSTIs infections in Europe, data regarding the prevalence of MRSA in SSTIs and the causative genotypes remain scarce. The paucity of literature on the prevalence of MSSA, MRSA and PVL-producing S. aureus strains in SSTI in Europe is probably due to the fact that culture and antimicrobial susceptibility testing is not a routine component of SSTI management. Setting-up a prospective multi-centre study involving patients presenting to emergency departments with SSTIs in several European countries would allow drawing a picture on the role and the respective contribution of MSSA, MRSA and PVL-producing S. aureus strains as a cause of SSTIs. However, the roles of emergency rooms and local policies with regard to performing microbiological analysis after surgical drainage of SSTIs vary between countries. In order to evaluate the feasibility of such multicenter European study, we aim at performing a pilot study based on few European clinical laboratories (five to seven) which will: i) evaluate the prevalence of MSSA, MRSA and S. aureus PVL-positive strains in community-acquired SSTIs; and ii) determine molecular characteristics of the isolated strains. The main objectives of this pilot study are to collect some preliminary information on the role of S. aureus in SSTIs and to determine factors that need to be harmonized or taken into consideration for the set-up a larger prospective cross-sectional study involving more European countries with several centers per country to cover different geographical areas per country.

NCT ID: NCT02607618 Completed - Clinical trials for Skin Structures and Soft Tissue Infections

Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2

REVIVE-2
Start date: November 2015
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.

NCT ID: NCT02600871 Completed - Clinical trials for Skin Diseases, Infectious

Skin and Soft Tissue Infection (SSTI) Study

Start date: December 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if the use Provodine as an antiseptic and hand wash once daily for at least 7 days will have better healing, better health outcomes, fewer treatment failures and fewer infections themselves and among their household contacts than those who do not use Provodine.

NCT ID: NCT02600611 Completed - Clinical trials for Skin Structures and Soft Tissue Infections

Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1

REVIVE-1
Start date: November 1, 2015
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.

NCT ID: NCT02501382 Completed - Clinical trials for Necrotizing Soft Tissue Infection

Modulation of Biomarkers in Patients With Flesh-eating Bacterial Infections After With Hyperbaric Oxygen Treatment

BIONEC-II
Start date: February 2013
Phase:
Study type: Observational

The purpose of this study is to investigate the effects of hyperic oxygen treatment on the immune response in patients with necrotizing soft tissue infections

NCT ID: NCT02469857 Completed - Clinical trials for Necrotizing Fasciitis

Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections

ACCUTE
Start date: December 1, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections (NSTI) receiving standard of care therapy.

NCT ID: NCT02378480 Completed - Clinical trials for Bacterial Infections

Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)

Start date: June 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to linezolid in the treatment of adults with acute bacterial skin and skin structure infections.

NCT ID: NCT02276482 Completed - Clinical trials for Skin Diseases, Infectious

Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012)

Start date: March 25, 2015
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the safety of intravenous (IV) and/or oral 6-day 200 mg tedizolid phosphate with 10-day comparator in participants 12 to <18 years with cSSTI.

NCT ID: NCT02180906 Completed - Clinical trials for Necrotizing Soft Tissue Infection

Biomarkers in Patients With Flesh-eating Bacterial Infections

BIONEC
Start date: February 2013
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the immune response in patients with necrotizing soft tissue infections (NSTI). The investigation will focus on inflammatory and vasoactive biomarkers as prognostic markers of severity and mortality at admission to Rigshospitalet and the following 3 days

NCT ID: NCT02142075 Completed - Renal Failure Clinical Trials

Population Pharmacokinetic (PK) Study of Multiple Doses of Cubicin® (Daptomycin) 10 mg/kg in Critical Care Patients Having Bacteremia, Endocarditis or Skin Soft Tissue Infections Due to Gram Positive Bacteria With Various Degrees of Renal Failure

DAPTOREA
Start date: March 2014
Phase: Phase 3
Study type: Interventional

Treatment of infections in critically ill patients remains a significant challenge to intensivists world-wide with persisting high mortality and morbidity. Compelling evidence suggests that source control of the pathogen and appropriate antibiotic therapy remain the most important interventions to improve patients' outcome, the latter including the administration of a suitable molecule at an optimized dosage regimen. Daptomycin is the first representative of a new family of antibiotics, the cyclic lipopeptides. Its bactericidal effect against Gram-positive bacteria, including meticillin-resistant strains, and its low renal toxicity, make it a useful antibiotic in critically ill patients having infections due to resistant Gram positive strains. Unfortunately, no PK study has been performed in infected critically ill patients without renal replacement therapy. A vast array of pathophysiological changes can occur in infected critically ill patients, leading to changes in volume of distribution and clearance of antibiotics in these patients, which may affect the antibiotic concentration at the target site. It is therefore important to better characterize daptomycin PK in infected patients with various degrees of renal failure in order to define optimal dosing regimens. This project aims to identify optimal daptomycin administration schemes in critical care patients with various degrees of renal impairment